Trial Outcomes & Findings for A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain (NCT NCT01931670)

Results Overview

The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

815 participants

Primary outcome timeframe

At Month 3 of the Treatment Period

Results posted on

2018-09-07

Participant Flow

Participants were randomized at 187 sites in Argentina, Austria, Australia, Brazil, Czech Republic, Hungary, Italy, New Zealand, Poland, South Africa, Spain, the United States, and the United Kingdom.

The study consisted of 4 periods: a Washout Period (if applicable); a Screening Period of ≤ 100 days prior to first dose; a 6-month Treatment Period; and a Post-Treatment Follow-up Period of ≤ 12 months (if applicable). Participants were randomized into the study in a 3:2:2 ratio to placebo, elagolix 150 mg QD, or elagolix 200 mg BID, respectively.

Participant milestones

Participant milestones
Measure	Placebo Placebo twice daily (BID) for the 6-month Treatment Period	Elagolix 150 mg QD Elagolix 150 mg once daily (QD) for the 6-month Treatment Period	Elagolix 200 mg BID Elagolix 200 mg BID for the 6-month Treatment Period
Treatment Period STARTED	360	226	229
Treatment Period COMPLETED	270	178	184
Treatment Period NOT COMPLETED	90	48	45
Post-Treatment Follow-Up (PTFU) Period STARTED	61	40	54
Post-Treatment Follow-Up (PTFU) Period Completed PTFU Month 6	42	24	18
Post-Treatment Follow-Up (PTFU) Period Completed PTFU Month 12	0	4	15
Post-Treatment Follow-Up (PTFU) Period COMPLETED	42	28	33
Post-Treatment Follow-Up (PTFU) Period NOT COMPLETED	19	12	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo twice daily (BID) for the 6-month Treatment Period	Elagolix 150 mg QD Elagolix 150 mg once daily (QD) for the 6-month Treatment Period	Elagolix 200 mg BID Elagolix 200 mg BID for the 6-month Treatment Period
Treatment Period Exclusionary Medication Received	1	1	1
Treatment Period Surgery/Invasive Intervention	4	2	0
Treatment Period Subject Noncompliant	4	9	5
Treatment Period Adverse Event	19	8	21
Treatment Period Lack of Efficacy	11	2	2
Treatment Period Pregnancy	7	2	0
Treatment Period Other	8	7	2
Treatment Period Consent Withdrawn by Subject	17	12	7
Treatment Period Lost to Follow-up	19	5	7
Post-Treatment Follow-Up (PTFU) Period Exclusionary Medication Received	3	0	0
Post-Treatment Follow-Up (PTFU) Period Adverse Event	0	2	1
Post-Treatment Follow-Up (PTFU) Period Surgery/Invasive Intervention	4	4	2
Post-Treatment Follow-Up (PTFU) Period Other	6	3	3
Post-Treatment Follow-Up (PTFU) Period Consent Withdrawn by Subject	6	3	13
Post-Treatment Follow-Up (PTFU) Period Lost to Follow-up	0	0	2

Baseline Characteristics

A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=360 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=226 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=229 Participants Elagolix 200 mg BID for the 6-month Treatment Period	Total n=815 Participants Total of all reporting groups
Age, Continuous	33.1 years STANDARD_DEVIATION 6.69 • n=5 Participants	33.1 years STANDARD_DEVIATION 6.80 • n=7 Participants	33.4 years STANDARD_DEVIATION 6.67 • n=5 Participants	33.2 years STANDARD_DEVIATION 6.71 • n=4 Participants
Sex: Female, Male Female	360 Participants n=5 Participants	226 Participants n=7 Participants	229 Participants n=5 Participants	815 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Month 3 of the Treatment Period

Population: The modified intent-to-treat (mITT) analysis set; all randomized participants who took at least 1 dose of randomized, double-blind study drug. Population included mITT participants who either had data during the Month 3 35-day window or who prematurely discontinued prior to or at Month 3 and met the rules for last observation carried forward.

The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.

Outcome measures

Outcome measures
Measure	Placebo n=353 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=221 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=225 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)	22.7 percentage of participants	43.4 percentage of participants	72.4 percentage of participants

PRIMARY outcome

Timeframe: At Month 3 of Treatment Period

Population: The mITT analysis set; all randomized participants who took at least 1 dose of randomized, double-blind study drug. Population included mITT participants who either had data during the Month 3 35-day window or who prematurely discontinued prior to or at Month 3 and met the rules for last observation carried forward.

The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.

Outcome measures

Outcome measures
Measure	Placebo n=353 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=221 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=225 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)	36.5 percentage of participants	49.8 percentage of participants	57.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 3 of the Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).

Outcome measures

Outcome measures
Measure	Placebo n=312 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=204 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=209 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores	-1.33 units on a scale Standard Error 0.097	-1.90 units on a scale Standard Error 0.122	-2.55 units on a scale Standard Error 0.122

SECONDARY outcome

Timeframe: Baseline, Month 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The DYS pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=273 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=185 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=187 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 6 in DYS	-0.52 units on a scale Standard Error 0.047	-1.06 units on a scale Standard Error 0.057	-1.65 units on a scale Standard Error 0.057

SECONDARY outcome

Timeframe: Baseline, Month 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

The NMPP pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=273 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=185 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=187 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 6 in NMPP	-0.48 units on a scale Standard Error 0.035	-0.63 units on a scale Standard Error 0.044	-0.80 units on a scale Standard Error 0.044

SECONDARY outcome

Timeframe: Baseline, Month 3 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.

Outcome measures

Outcome measures
Measure	Placebo n=312 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=204 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=209 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics	-0.31 number of pills Standard Error 0.028	-0.36 number of pills Standard Error 0.035	-0.49 number of pills Standard Error 0.034

SECONDARY outcome

Timeframe: Baseline, Month 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.

Outcome measures

Outcome measures
Measure	Placebo n=273 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=185 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=187 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics	-0.32 number of pills Standard Error 0.030	-0.40 number of pills Standard Error 0.038	-0.52 number of pills Standard Error 0.037

SECONDARY outcome

Timeframe: Baseline, Month 3 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis.

The DYSP pain scale ranges from 0 (absent) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=226 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=145 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=150 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in Dyspareunia (DYSP)	-0.30 units on a scale Standard Error 0.042	-0.39 units on a scale Standard Error 0.052	-0.60 units on a scale Standard Error 0.052

SECONDARY outcome

Timeframe: Baseline, Month 3 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

Permitted country-specific rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen. Assessment was based on average pill counts.

Outcome measures

Outcome measures
Measure	Placebo n=312 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=204 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=209 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)	-0.12 number of pills Standard Error 0.019	-0.12 number of pills Standard Error 0.024	-0.21 number of pills Standard Error 0.023

SECONDARY outcome

Timeframe: Months 1, 2, 4, 5, 6 of the Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. Participants with an assessment at given time point.

The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.

Outcome measures

Outcome measures
Measure	Placebo n=358 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=221 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=225 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders for Each Month, Except Month 3, in DYS Month 1	17.3 percentage of participants	33.0 percentage of participants	46.2 percentage of participants
Percentage of Responders for Each Month, Except Month 3, in DYS Month 2	19.0 percentage of participants	39.4 percentage of participants	69.8 percentage of participants
Percentage of Responders for Each Month, Except Month 3, in DYS Month 4	21.2 percentage of participants	45.9 percentage of participants	79.8 percentage of participants
Percentage of Responders for Each Month, Except Month 3, in DYS Month 5	23.7 percentage of participants	44.1 percentage of participants	80.7 percentage of participants
Percentage of Responders for Each Month, Except Month 3, in DYS Month 6	25.4 percentage of participants	46.2 percentage of participants	76.9 percentage of participants

SECONDARY outcome

Timeframe: Months 1, 2, 4, 5, 6 of the Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. Participants with an assessment at given time point.

The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.

Outcome measures

Outcome measures
Measure	Placebo n=358 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=221 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=225 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders for Each Month, Except Month 3, in NMPP Month 1	23.5 percentage of participants	27.6 percentage of participants	29.3 percentage of participants
Percentage of Responders for Each Month, Except Month 3, in NMPP Month 2	32.1 percentage of participants	39.8 percentage of participants	50.7 percentage of participants
Percentage of Responders for Each Month, Except Month 3, in NMPP Month 4	38.7 percentage of participants	51.4 percentage of participants	63.2 percentage of participants
Percentage of Responders for Each Month, Except Month 3, in NMPP Month 5	39.8 percentage of participants	50.5 percentage of participants	63.2 percentage of participants
Percentage of Responders for Each Month, Except Month 3, in NMPP Month 6	40.6 percentage of participants	51.6 percentage of participants	62.2 percentage of participants

SECONDARY outcome

Timeframe: Months 1, 2, 3, 4, 5, 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. Participants with an assessment at given time point.

The DYSP pain scale ranged from 0 (absent) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.29 or greater from Baseline in DYSP as well as no increased rescue analgesic use for endometriosis-associated pain.

Outcome measures

Outcome measures
Measure	Placebo n=262 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=168 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=171 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percentage of Responders at Each Month for DYSP Month 1	33.3 percentage of participants	33.8 percentage of participants	35.1 percentage of participants
Percentage of Responders at Each Month for DYSP Month 2	33.2 percentage of participants	39.9 percentage of participants	47.4 percentage of participants
Percentage of Responders at Each Month for DYSP Month 3	39.5 percentage of participants	44.0 percentage of participants	53.7 percentage of participants
Percentage of Responders at Each Month for DYSP Month 4	38.5 percentage of participants	41.3 percentage of participants	59.8 percentage of participants
Percentage of Responders at Each Month for DYSP Month 5	37.4 percentage of participants	42.8 percentage of participants	58.1 percentage of participants
Percentage of Responders at Each Month for DYSP Month 6	39.4 percentage of participants	39.9 percentage of participants	55.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Prior to administering study drug), Months 1, 2, 3, 4, 5 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.

The DYS pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=358 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=221 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=225 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS Month 1	-0.33 units on a scale Standard Error 0.044	-0.86 units on a scale Standard Error 0.056	-1.11 units on a scale Standard Error 0.056
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS Month 2	-0.39 units on a scale Standard Error 0.042	-0.84 units on a scale Standard Error 0.053	-1.67 units on a scale Standard Error 0.053
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS Month 3	-0.45 units on a scale Standard Error 0.042	-0.97 units on a scale Standard Error 0.053	-1.70 units on a scale Standard Error 0.052
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS Month 4	-0.47 units on a scale Standard Error 0.044	-1.05 units on a scale Standard Error 0.054	-1.74 units on a scale Standard Error 0.054
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS Month 5	-0.50 units on a scale Standard Error 0.045	-0.99 units on a scale Standard Error 0.055	-1.76 units on a scale Standard Error 0.055

SECONDARY outcome

Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.

The DYS pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=358 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=221 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=224 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percent Change From Baseline to Each Month in Mean Pain Score for DYS Month 1	-14.36 percentage change Standard Error 2.268	-39.67 percentage change Standard Error 2.886	-53.68 percentage change Standard Error 2.867
Percent Change From Baseline to Each Month in Mean Pain Score for DYS Month 2	-17.36 percentage change Standard Error 2.087	-39.26 percentage change Standard Error 2.629	-80.68 percentage change Standard Error 2.638
Percent Change From Baseline to Each Month in Mean Pain Score for DYS Month 3	-20.58 percentage change Standard Error 2.031	-45.73 percentage change Standard Error 2.528	-82.52 percentage change Standard Error 2.513
Percent Change From Baseline to Each Month in Mean Pain Score for DYS Month 4	-21.55 percentage change Standard Error 2.104	-48.52 percentage change Standard Error 2.601	-83.92 percentage change Standard Error 2.599
Percent Change From Baseline to Each Month in Mean Pain Score for DYS Month 5	-22.63 percentage change Standard Error 2.159	-45.99 percentage change Standard Error 2.664	-85.53 percentage change Standard Error 2.650
Percent Change From Baseline to Each Month in Mean Pain Score for DYS Month 6	-23.81 percentage change Standard Error 2.225	-49.70 percentage change Standard Error 2.738	-80.43 percentage change Standard Error 2.727

SECONDARY outcome

Timeframe: Baseline, Months 1, 2, 3, 4, 5 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.

The NMPP pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=358 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=221 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=225 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP Month 1	-0.22 units on a scale Standard Error 0.025	-0.24 units on a scale Standard Error 0.031	-0.31 units on a scale Standard Error 0.031
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP Month 2	-0.34 units on a scale Standard Error 0.027	-0.41 units on a scale Standard Error 0.034	-0.54 units on a scale Standard Error 0.034
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP Month 3	-0.39 units on a scale Standard Error 0.031	-0.50 units on a scale Standard Error 0.039	-0.69 units on a scale Standard Error 0.039
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP Month 4	-0.45 units on a scale Standard Error 0.033	-0.54 units on a scale Standard Error 0.041	-0.78 units on a scale Standard Error 0.041
Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP Month 5	-0.48 units on a scale Standard Error 0.034	-0.58 units on a scale Standard Error 0.042	-0.81 units on a scale Standard Error 0.042

SECONDARY outcome

Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.

The NMPP pain scale ranges from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=358 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=221 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=225 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP Month 1	-12.43 percentage change Standard Deviation 1.814	-15.47 percentage change Standard Deviation 2.313	-18.86 percentage change Standard Deviation 2.288
Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP Month 2	-21.13 percentage change Standard Deviation 1.836	-26.30 percentage change Standard Deviation 2.326	-34.32 percentage change Standard Deviation 2.316
Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP Month 3	-25.78 percentage change Standard Deviation 2.104	-32.63 percentage change Standard Deviation 2.643	-44.83 percentage change Standard Deviation 2.625
Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP Month 4	-29.94 percentage change Standard Deviation 2.170	-36.19 percentage change Standard Deviation 2.711	-51.52 percentage change Standard Deviation 2.696
Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP Month 5	-31.96 percentage change Standard Deviation 2.214	-38.17 percentage change Standard Deviation 2.756	-53.61 percentage change Standard Deviation 2.737
Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP Month 6	-31.25 percentage change Standard Deviation 2.349	-42.09 percentage change Standard Deviation 2.914	-52.42 percentage change Standard Deviation 2.897

SECONDARY outcome

Timeframe: Baseline, Months 1, 2, 4, 5, 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis. Participants with an assessment at given timepoint.

The DYSP pain scale ranged from 0 (absent) to 3 (severe).

Outcome measures

Outcome measures
Measure	Placebo n=261 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=161 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=171 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP Month 2	-0.25 units on a scale Standard Error 0.038	-0.32 units on a scale Standard Error 0.047	-0.49 units on a scale Standard Error 0.047
Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP Month 1	-0.21 units on a scale Standard Error 0.037	-0.19 units on a scale Standard Error 0.046	-0.26 units on a scale Standard Error 0.045
Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP Month 4	-0.35 units on a scale Standard Error 0.045	-0.40 units on a scale Standard Error 0.055	-0.63 units on a scale Standard Error 0.055
Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP Month 5	-0.39 units on a scale Standard Error 0.046	-0.41 units on a scale Standard Error 0.056	-0.70 units on a scale Standard Error 0.056
Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP Month 6	-0.36 units on a scale Standard Error 0.049	-0.42 units on a scale Standard Error 0.058	-0.69 units on a scale Standard Error 0.058

SECONDARY outcome

Timeframe: Baseline, Months 1, 2, 4, 5

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.

Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.

Outcome measures

Outcome measures
Measure	Placebo n=358 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=221 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=225 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics Month 1	-0.20 number of pills Standard Error 0.024	-0.29 number of pills Standard Error 0.031	-0.32 number of pills Standard Error 0.031
Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics Month 2	-0.25 number of pills Standard Error 0.026	-0.32 number of pills Standard Error 0.033	-0.44 number of pills Standard Error 0.033
Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics Month 4	-0.29 number of pills Standard Error 0.028	-0.38 number of pills Standard Error 0.035	-0.51 number of pills Standard Error 0.035
Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics Month 5	-0.32 number of pills Standard Error 0.030	-0.37 number of pills Standard Error 0.038	-0.54 number of pills Standard Error 0.038

SECONDARY outcome

Timeframe: Months 1, 2, 3, 4, 5, 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. Participants with an assessment at given time point.

The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.

Outcome measures

Outcome measures
Measure	Placebo n=337 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=214 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=215 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Patient Global Impression of Change (PGIC) Questionnaire Month 1	3.49 units on a scale Standard Error 0.062	3.12 units on a scale Standard Error 0.078	2.84 units on a scale Standard Error 0.077
Patient Global Impression of Change (PGIC) Questionnaire Month 2	3.24 units on a scale Standard Error 0.063	2.62 units on a scale Standard Error 0.079	2.15 units on a scale Standard Error 0.079
Patient Global Impression of Change (PGIC) Questionnaire Month 3	3.16 units on a scale Standard Error 0.066	2.53 units on a scale Standard Error 0.083	2.02 units on a scale Standard Error 0.083
Patient Global Impression of Change (PGIC) Questionnaire Month 4	3.19 units on a scale Standard Error 0.068	2.56 units on a scale Standard Error 0.085	1.97 units on a scale Standard Error 0.085
Patient Global Impression of Change (PGIC) Questionnaire Month 5	3.23 units on a scale Standard Error 0.070	2.43 units on a scale Standard Error 0.088	1.98 units on a scale Standard Error 0.088
Patient Global Impression of Change (PGIC) Questionnaire Month 6	3.22 units on a scale Standard Error 0.073	2.50 units on a scale Standard Error 0.090	1.95 units on a scale Standard Error 0.091

SECONDARY outcome

Timeframe: Baseline, Months 1, 2, 4, 5, 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.

The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).

Outcome measures

Outcome measures
Measure	Placebo n=358 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=221 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=225 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Each Month, Except Month 3, in NRS Scores Month 1	-0.78 units on a scale Standard Error 0.074	-1.06 units on a scale Standard Error 0.094	-1.23 units on a scale Standard Error 0.093
Change From Baseline to Each Month, Except Month 3, in NRS Scores Month 2	-1.08 units on a scale Standard Error 0.085	-1.62 units on a scale Standard Error 0.108	-2.04 units on a scale Standard Error 0.107
Change From Baseline to Each Month, Except Month 3, in NRS Scores Month 4	-1.49 units on a scale Standard Error 0.102	-2.06 units on a scale Standard Error 0.128	-2.84 units on a scale Standard Error 0.128
Change From Baseline to Each Month, Except Month 3, in NRS Scores Month 5	-1.58 units on a scale Standard Error 0.105	-2.19 units on a scale Standard Error 0.131	-2.95 units on a scale Standard Error 0.131
Change From Baseline to Each Month, Except Month 3, in NRS Scores Month 6	-1.60 units on a scale Standard Error 0.110	-2.28 units on a scale Standard Error 0.137	-2.87 units on a scale Standard Error 0.136

SECONDARY outcome

Timeframe: Baseline, Months 1, 3, 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.

The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.

Outcome measures

Outcome measures
Measure	Placebo n=331 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=213 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=213 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores Month 1	-15.20 units on a scale Standard Error 0.971	-19.40 units on a scale Standard Error 1.210	-22.75 units on a scale Standard Error 1.211
Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores Month 3	-19.29 units on a scale Standard Error 1.103	-26.62 units on a scale Standard Error 1.349	-34.72 units on a scale Standard Error 1.360
Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores Month 6	-19.53 units on a scale Standard Error 1.340	-28.23 units on a scale Standard Error 1.601	-36.44 units on a scale Standard Error 1.572

SECONDARY outcome

Timeframe: Baseline, Months 1, 3, 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.

The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.

Outcome measures

Outcome measures
Measure	Placebo n=226 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=150 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=155 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores Month 1	-9.89 units on a scale Standard Error 1.229	-10.46 units on a scale Standard Error 1.510	-14.29 units on a scale Standard Error 1.484
Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores Month 3	-14.51 units on a scale Standard Error 1.502	-17.26 units on a scale Standard Error 1.895	-25.20 units on a scale Standard Error 1.848
Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores Month 6	-14.14 units on a scale Standard Error 1.891	-17.07 units on a scale Standard Error 2.215	-28.24 units on a scale Standard Error 2.095

SECONDARY outcome

Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.

The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.

Outcome measures

Outcome measures
Measure	Placebo n=239 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=150 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=146 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism Month 1	-0.61 hours Standard Error 0.267	-1.62 hours Standard Error 0.336	-1.56 hours Standard Error 0.341
Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism Month 2	-0.82 hours Standard Error 0.246	-1.80 hours Standard Error 0.312	-2.25 hours Standard Error 0.312
Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism Month 3	-0.76 hours Standard Error 0.268	-1.43 hours Standard Error 0.338	-2.17 hours Standard Error 0.336
Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism Month 4	-0.55 hours Standard Error 0.355	-1.81 hours Standard Error 0.434	-2.03 hours Standard Error 0.426
Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism Month 5	-0.85 hours Standard Error 0.209	-1.58 hours Standard Error 0.251	-1.96 hours Standard Error 0.251
Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism Month 6	-0.76 hours Standard Error 0.246	-1.34 hours Standard Error 0.303	-1.67 hours Standard Error 0.296

SECONDARY outcome

Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.

The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.

Outcome measures

Outcome measures
Measure	Placebo n=272 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=178 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=187 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism Month 1	-1.45 hours Standard Error 0.261	-2.08 hours Standard Error 0.322	-2.30 hours Standard Error 0.315
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism Month 2	-1.63 hours Standard Error 0.269	-2.75 hours Standard Error 0.327	-3.06 hours Standard Error 0.330
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism Month 3	-2.03 hours Standard Error 0.274	-2.95 hours Standard Error 0.336	-2.94 hours Standard Error 0.333
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism Month 4	-2.21 hours Standard Error 0.285	-2.55 hours Standard Error 0.353	-3.54 hours Standard Error 0.324
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism Month 5	-1.87 hours Standard Error 0.284	-2.99 hours Standard Error 0.340	-3.51 hours Standard Error 0.334
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism Month 6	-1.89 hours Standard Error 0.306	-2.61 hours Standard Error 0.368	-3.34 hours Standard Error 0.336

SECONDARY outcome

Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.

The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism \[working while sick\]) in the 7 days prior to survey administration.

Outcome measures

Outcome measures
Measure	Placebo n=235 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=145 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=143 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism Month 1	-1.60 hours Standard Error 0.623	-2.94 hours Standard Error 0.793	-4.69 hours Standard Error 0.798
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism Month 2	-3.43 hours Standard Error 0.621	-4.74 hours Standard Error 0.790	-7.08 hours Standard Error 0.792
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism Month 3	-4.07 hours Standard Error 0.633	-6.10 hours Standard Error 0.799	-7.27 hours Standard Error 0.801
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism Month 4	-4.58 hours Standard Error 0.629	-6.21 hours Standard Error 0.774	-9.35 hours Standard Error 0.764
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism Month 5	-4.37 hours Standard Error 0.618	-6.66 hours Standard Error 0.747	-9.51 hours Standard Error 0.753
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism Month 6	-6.11 hours Standard Error 0.692	-7.08 hours Standard Error 0.869	-9.13 hours Standard Error 0.845

SECONDARY outcome

Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.

The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism \[working while sick\]) in the 7 days prior to survey administration.

Outcome measures

Outcome measures
Measure	Placebo n=266 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=175 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=185 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism Month 1	-0.71 hours Standard Error 0.266	-0.69 hours Standard Error 0.327	-0.72 hours Standard Error 0.319
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism Month 2	-1.06 hours Standard Error 0.247	-1.28 hours Standard Error 0.301	-1.46 hours Standard Error 0.305
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism Month 3	-1.31 hours Standard Error 0.318	-0.88 hours Standard Error 0.392	-1.46 hours Standard Error 0.392
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism Month 4	-1.26 hours Standard Error 0.308	-1.19 hours Standard Error 0.383	-2.19 hours Standard Error 0.353
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism Month 5	-0.78 hours Standard Error 0.406	-1.68 hours Standard Error 0.488	-1.69 hours Standard Error 0.482
Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism Month 6	-1.44 hours Standard Error 0.318	-2.27 hours Standard Error 0.383	-2.29 hours Standard Error 0.351

SECONDARY outcome

Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.

The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.

Outcome measures

Outcome measures
Measure	Placebo n=239 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=150 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=146 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace Month 1	-2.19 hours Standard Error 0.686	-4.02 hours Standard Error 0.865	-5.91 hours Standard Error 0.875
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace Month 2	-4.25 hours Standard Error 0.674	-6.27 hours Standard Error 0.856	-9.36 hours Standard Error 0.854
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace Month 3	-4.66 hours Standard Error 0.708	-7.31 hours Standard Error 0.891	-9.30 hours Standard Error 0.886
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace Month 4	-4.87 hours Standard Error 0.721	-7.58 hours Standard Error 0.879	-11.14 hours Standard Error 0.862
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace Month 5	-5.32 hours Standard Error 0.701	-7.81 hours Standard Error 0.839	-11.15 hours Standard Error 0.839
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace Month 6	-6.73 hours Standard Error 0.793	-8.01 hours Standard Error 0.980	-10.70 hours Standard Error 0.953

SECONDARY outcome

Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.

The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.

Outcome measures

Outcome measures
Measure	Placebo n=272 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=178 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=187 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household Month 1	-2.18 hours Standard Error 0.390	-2.78 hours Standard Error 0.482	-2.89 hours Standard Error 0.470
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household Month 2	-2.71 hours Standard Error 0.415	-4.04 hours Standard Error 0.503	-4.48 hours Standard Error 0.508
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household Month 3	-3.37 hours Standard Error 0.448	-3.84 hours Standard Error 0.551	-4.34 hours Standard Error 0.546
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household Month 4	-3.46 hours Standard Error 0.463	-3.77 hours Standard Error 0.574	-5.64 hours Standard Error 0.528
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household Month 5	-2.62 hours Standard Error 0.549	-4.67 hours Standard Error 0.657	-5.16 hours Standard Error 0.646
Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household Month 6	-3.30 hours Standard Error 0.497	-4.89 hours Standard Error 0.598	-5.58 hours Standard Error 0.546

SECONDARY outcome

Timeframe: Months 1, 2, 3, 4, 5, 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug.

This is assessed using Health Resource Utilization Questionnaire (HRUQ).

Outcome measures

Outcome measures
Measure	Placebo n=360 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=226 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=229 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period Baseline	99 Participants	53 Participants	57 Participants
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period Month 1	93 Participants	47 Participants	54 Participants
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period Month 2	72 Participants	42 Participants	43 Participants
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period Month 3	54 Participants	46 Participants	40 Participants
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period Month 4	62 Participants	39 Participants	43 Participants
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period Month 5	56 Participants	31 Participants	30 Participants
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period Month 6	39 Participants	27 Participants	25 Participants
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period Overall	201 Participants	124 Participants	131 Participants

SECONDARY outcome

Timeframe: Up to Month 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Includes participants who were hospitalized during the Treatment Period.

This is assessed using HRUQ.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=16 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=12 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Number of Days of Hospitalization	3.2 days Standard Deviation 2.18	3.3 days Standard Deviation 3.52	2.2 days Standard Deviation 1.27

SECONDARY outcome

Timeframe: Up to Month 6 of Treatment Period

Population: The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug.

This is assessed using HRUQ.

Outcome measures

Outcome measures
Measure	Placebo n=360 Participants Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=226 Participants Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=229 Participants Elagolix 200 mg BID for the 6-month Treatment Period
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Ultrasound	9 Participants	3 Participants	2 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Urine Test	8 Participants	7 Participants	6 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type All Categories	37 Participants	28 Participants	22 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Abdominal Hysterectomy	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Angiography	0 Participants	1 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Arthroscopy	0 Participants	0 Participants	1 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Biopsy	0 Participants	1 Participants	1 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Blood Draw	12 Participants	13 Participants	4 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Colposcopy	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Consultation	1 Participants	5 Participants	1 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type CT Scan	7 Participants	10 Participants	5 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Diagnostic Laparoscopy	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Electrocardiogram	4 Participants	2 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Endometrial Ablation	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Histological Exam	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Intrauterine Insemination	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type In Vitro Fertilization	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Laparoscopic Hysterectomy	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Laparotomy	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Magnetic Resonance Imaging	0 Participants	2 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Oophorectomy	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Pelvic Exam	3 Participants	0 Participants	2 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Physical Examination	18 Participants	16 Participants	14 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Surgery for Adhesions	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Therapeutic Laparoscopy	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Transfusion	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Vaginal Hysterectomy	0 Participants	0 Participants	0 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type X-Ray	12 Participants	11 Participants	7 Participants
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type Other (Not Specified)	13 Participants	4 Participants	4 Participants

Adverse Events

Placebo

Serious events: 12 serious events

Other events: 158 other events

Deaths: 0 deaths

Elagolix 150 mg QD

Serious events: 12 serious events

Other events: 128 other events

Deaths: 1 deaths

Elagolix 200 mg BID

Serious events: 5 serious events

Other events: 162 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=360 participants at risk Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=226 participants at risk Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=229 participants at risk Elagolix 200 mg BID for the 6-month Treatment Period
Gastrointestinal disorders DIARRHOEA	5.0% 18/360 • Number of events 18 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	3.5% 8/226 • Number of events 8 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	4.8% 11/229 • Number of events 11 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Gastrointestinal disorders NAUSEA	11.1% 40/360 • Number of events 40 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	11.5% 26/226 • Number of events 26 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	15.7% 36/229 • Number of events 36 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Infections and infestations NASOPHARYNGITIS	5.8% 21/360 • Number of events 21 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	6.6% 15/226 • Number of events 15 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	7.0% 16/229 • Number of events 16 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Infections and infestations SINUSITIS	3.9% 14/360 • Number of events 14 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	4.4% 10/226 • Number of events 10 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	6.6% 15/229 • Number of events 15 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	4.4% 16/360 • Number of events 16 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	4.9% 11/226 • Number of events 11 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	5.2% 12/229 • Number of events 12 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Infections and infestations URINARY TRACT INFECTION	7.2% 26/360 • Number of events 26 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	4.4% 10/226 • Number of events 10 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	8.3% 19/229 • Number of events 19 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Musculoskeletal and connective tissue disorders ARTHRALGIA	3.1% 11/360 • Number of events 11 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	3.1% 7/226 • Number of events 7 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	7.0% 16/229 • Number of events 16 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Musculoskeletal and connective tissue disorders BACK PAIN	4.2% 15/360 • Number of events 15 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	3.5% 8/226 • Number of events 8 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	5.7% 13/229 • Number of events 13 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Nervous system disorders HEADACHE	13.9% 50/360 • Number of events 50 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	18.6% 42/226 • Number of events 42 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	22.7% 52/229 • Number of events 52 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Psychiatric disorders INSOMNIA	3.3% 12/360 • Number of events 12 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	5.8% 13/226 • Number of events 13 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	10.5% 24/229 • Number of events 24 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Psychiatric disorders MOOD SWINGS	2.2% 8/360 • Number of events 8 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	5.8% 13/226 • Number of events 13 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	2.6% 6/229 • Number of events 6 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Reproductive system and breast disorders AMENORRHOEA	0.28% 1/360 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	4.9% 11/226 • Number of events 11 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	8.7% 20/229 • Number of events 20 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Vascular disorders HOT FLUSH	10.3% 37/360 • Number of events 37 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	22.6% 51/226 • Number of events 51 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	47.6% 109/229 • Number of events 109 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.

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Measure	Placebo n=360 participants at risk Placebo BID for the 6-month Treatment Period	Elagolix 150 mg QD n=226 participants at risk Elagolix 150 mg QD for the 6-month Treatment Period	Elagolix 200 mg BID n=229 participants at risk Elagolix 200 mg BID for the 6-month Treatment Period
Gastrointestinal disorders ABDOMINAL PAIN	0.83% 3/360 • Number of events 3 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.88% 2/226 • Number of events 2 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Gastrointestinal disorders FREQUENT BOWEL MOVEMENTS	0.00% 0/360 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.44% 1/226 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Gastrointestinal disorders LARGE INTESTINAL OBSTRUCTION	0.28% 1/360 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/226 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Gastrointestinal disorders NAUSEA	0.28% 1/360 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/226 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Infections and infestations ABSCESS ORAL	0.00% 0/360 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.44% 1/226 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Infections and infestations APPENDICITIS	0.00% 0/360 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/226 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.87% 2/229 • Number of events 2 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Infections and infestations PHARYNGEAL ABSCESS	0.00% 0/360 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/226 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.44% 1/229 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Infections and infestations POSTOPERATIVE ABSCESS	0.00% 0/360 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/226 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.44% 1/229 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Infections and infestations URINARY TRACT INFECTION	0.28% 1/360 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/226 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Injury, poisoning and procedural complications LIGAMENT SPRAIN	0.00% 0/360 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/226 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.44% 1/229 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.00% 0/360 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.44% 1/226 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/360 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.88% 2/226 • Number of events 2 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.00% 0/360 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.44% 1/226 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Musculoskeletal and connective tissue disorders JAW CYST	0.00% 0/360 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/226 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.44% 1/229 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Nervous system disorders DIZZINESS	0.28% 1/360 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/226 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Nervous system disorders HEADACHE	0.28% 1/360 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/226 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Nervous system disorders LUMBAR RADICULOPATHY	0.00% 0/360 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.44% 1/226 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Nervous system disorders SYNCOPE	0.28% 1/360 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/226 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Pregnancy, puerperium and perinatal conditions ABORTION SPONTANEOUS	0.00% 0/360 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.44% 1/226 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Pregnancy, puerperium and perinatal conditions ABORTION SPONTANEOUS COMPLETE	0.56% 2/360 • Number of events 2 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/226 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Psychiatric disorders COMPLETED SUICIDE	0.00% 0/360 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.44% 1/226 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Renal and urinary disorders RENAL COLIC	0.00% 0/360 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.44% 1/226 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Reproductive system and breast disorders ENDOMETRIOSIS	0.28% 1/360 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.88% 2/226 • Number of events 2 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Reproductive system and breast disorders MENORRHAGIA	0.00% 0/360 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.44% 1/226 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Reproductive system and breast disorders PELVIC PAIN	0.28% 1/360 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/226 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Reproductive system and breast disorders PERINEAL PAIN	0.28% 1/360 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/226 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Reproductive system and breast disorders UTERINE POLYP	0.00% 0/360 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.88% 2/226 • Number of events 2 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Reproductive system and breast disorders VAGINAL HAEMORRHAGE	0.00% 0/360 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.44% 1/226 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Surgical and medical procedures ABORTION INDUCED	0.28% 1/360 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.44% 1/226 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Vascular disorders BLOOD PRESSURE FLUCTUATION	0.28% 1/360 • Number of events 1 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/226 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.	0.00% 0/229 • From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.